The Nagoya Protocol and the EU ABS Regulation

The Nagoya Protocol

The Nagoya Protocol is an international agreement on genetic resources and associated traditional knowledge.

The protocol regulates how the genetic resource is to be obtained, how it is to be used in research and product development, and how profit from its utilisation is to be allocated.

What are genetic resources?

Genetic resources can be plants, animals or parts thereof, such as seeds, spores, sperm as well as yeast cells, viruses and bacteria.

The Convention on Biological Diversity defines genetic resources as “genetic material of actual or potential value” and “every material of plant, animal, microorganism or other original that contains functional units of genetic heritage”.

How are they used?

Genetic resources can be used in the development of products such as pharmaceuticals, cosmetics and biofuel. A genetic resource can also be used in basic research in, for example, ecology and biomedicine.

They play a key and increasingly prominent role in several economic sectors, such as food production and forestry, as well as in the development of pharmaceuticals, cosmetics and bio-based energy sources.

Genetic resources are very important in measures taken to restore damaged ecosystems and biological diversity.

Traditional knowledge related to genetic resources

Traditional knowledge possessed by aboriginal peoples and local communities that maintain a traditional lifestyle can provide important clues for scientific discoveries. This includes knowledge, innovations and customs for the preservation and sustainable use of biological diversity.

In many cases, this knowledge has been passed from mouth to mouth over generations and can be found in stories, legends, folklore, rituals, songs and laws.

National legislation in different countries differs as regards the definition of traditional knowledge. It is therefore important that users who are uncertain whether their research encompasses traditional knowledge contact the country from which the genetic resource and associated traditional knowledge was obtained.

Provisions for users are contained in the ABS Regulation

The ABS Regulation (Access and Benefit-Sharing), EU Regulation 511/2014, encompasses all of the member states of the EU, and

applies as of 12 October 2015;

applies to the genetic resources for which access occurred after 12 October 2014; and

applies when access to a genetic resource, or traditional knowledge that affects the genetic resource, has occurred in a country (in or outside the EU) that is a signatory to the Nagoya Protocol and that has introduced national legislation regulating access to its genetic resources.

Exceptions

The Regulation does not apply to the human genome nor for genetic resources used within the framework of the International Treaty for Plant Genetic Resources and for pathogens that cause a prevailing or imminent international threat to human health (see also the ABS Regulation).

What is the implication of the legislation on the user?

Users of genetic resources and traditional knowledge pertaining to genetic resources must comply with the ABS Regulation on the implementation of the Nagoya Protocol by declaring so-called due diligence.

This means the user must show that the genetic resource, and/or the traditional knowledge that relates to the genetic resource, was obtained in accordance with applicable legislation in the country in question. Additionally, the potential benefit of the genetic resource, and/or traditional knowledge that relates to the genetic resource, must be distributed in a reasonable and fair manner, in accordance with agreed terms and conditions.

The application may apply to several forms of use – for example, the development of pharmaceuticals, cosmetic products or health preparations – as well as to basic research, such as ecological and taxonomic research.

Registered collection

Under the ABS Regulation a holder of a collection of genetic resources can have it registered with the European Commission. It must meet special criteria such that the genetic resources in the collection have been collected with due diligence.

This means that users of genetic resources from a registered collection do themselves need to fulfil due diligence requirements. Instead, the users must be able to show that the genetic resources are from a registered collection.

In a longer perspective, this means the use of the non-registered collections will probably decline.

How will the ABS Regulation be applied in Sweden?

Sweden is party to the Nagoya protocol since December 7th, 2016. An additional Swedish regulation on the utilisation of genetic resources and associated traditional knowledge entered into force october 1st 2016 (SFS 2016:858).

Users in Sweden shall be able to demonstrate that they are complying with applicable legislation when accessing and utilising genetic resources and associated traditional knowledge in countries that are party to the protocol. This should also be documented in a way that complies with the inspection process.